ISO 7886-1-2017 (2019) PDF

Full title and description

St ISO 7886-1-2017 (2019) — Sterile hypodermic syringes for single use — Part 1: Syringes for manual use. Specifies design requirements and test methods for empty sterile single‑use hypodermic syringes (with or without needle) made of plastic or other materials, intended to be filled and used immediately by end users for aspiration and injection of fluids.

Abstract

Specifies requirements and test methods to verify the design and performance of empty sterile single‑use hypodermic syringes for manual use (plastic or other materials), including dimensional, functional and marking requirements. Excludes insulin syringes, glass syringes, prefilled syringes, syringes for long‑term storage and certain pump-use syringes. Corrected editions (English and French) were issued in August 2019.

General information

• Status: Published / current (confirmed by ISO review process).
• Publication date: May 2017 (Edition 2); corrected version (English and French) August 2019).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.25 — Syringes, needles and catheters; related to transfusion, infusion and injection equipment.
• Edition / version: Edition 2 (2017), corrected version issued August 2019).
• Number of pages: 28.

Scope

Applies to sterile single‑use hypodermic syringes for manual use of nominal capacities typically intended to be filled by the end user and used immediately. The standard defines design, material, marking and performance requirements and specifies test methods for dimensional checks, leakage, dead space, plunger movement, stopper retention and other functional attributes. It explicitly excludes insulin syringes (ISO 8537), single‑use glass syringes, prefilled syringes, syringes intended for extended storage and syringes specifically for power‑driven pumps (covered by Part 2).

Key topics and requirements

• Design and materials: requirements to ensure compatibility with intended use and basic biocompatibility considerations.
• Dimensions and tolerances: barrel, flange, plunger and tip dimensions and centering/excentering rules for different capacities.
• Functional tests: plunger movement, pull‑out force, stopper retention (must not detach), freedom from leakage and air ingress.
• Dead space: methods for determination and limits relevant to dosing accuracy.
• Marking and labelling: barrel graduations, capacity marking, “For single use” (or equivalent symbol), manufacturer identification, lot/batch marking and expiry information; unit and multipack marking requirements.
• Connector compatibility: requirements referencing small‑bore connector standards where applicable (e.g., conical fittings to ISO 80369‑7 where relevant).
• Sterility and packaging marking: requirements for unit packaging marking (e.g., “STERILE”), package integrity warnings and sterilization method symbols where applicable.
• Test methods and acceptance criteria: detailed procedures for verification of the above performance and dimensional requirements (including annexed test methods).

Typical use and users

Used by medical device manufacturers (design and quality teams), test and certification laboratories, regulatory affairs professionals, hospital procurement and clinical engineering, and conformity assessment bodies. Also referenced by product designers for compliance, by suppliers preparing technical documentation, and by clinicians and risk managers evaluating device selection and usability. Test houses use the standard’s methods when performing verification and performance testing.

Related standards

Key related documents in the ISO 7886 series and other relevant standards include: ISO 7886‑2 (Syringes for use with power‑driven syringe pumps), ISO 7886‑3 (auto‑disable syringes; earlier editions and newer revisions), ISO 7886‑4 (syringes with re‑use prevention feature), ISO 7864 (sterile hypodermic needles), ISO 8537 (insulin syringes), ISO 80369‑7 (small bore connectors — conical fittings), ISO 15223‑1 (medical device symbols), ISO 14971 (risk management) and IEC 62366 (usability).

Keywords

hypodermic syringe, sterile syringe, single‑use syringe, syringe design, plunger, stopper, dead space, leakage test, ISO 7886, medical device standard, syringe marking, connector ISO 80369‑7

FAQ

Q: What is this standard?

A: ISO 7886‑1:2017 (corrected 2019) is the international standard that specifies design, performance and test requirements for sterile single‑use hypodermic syringes intended for manual use.

Q: What does it cover?

A: It covers empty sterile single‑use syringes (plastic or other materials) intended to be filled by end users and used immediately — specifying dimensional, functional and marking requirements and test methods (dead space, leakage, plunger function, stopper retention, markings, packaging). It excludes insulin syringes, glass syringes, prefilled syringes and syringes intended for long‑term storage; syringes for pumps are covered in Part 2.

Q: Who typically uses it?

A: Manufacturers (design/QA), test laboratories, regulatory and compliance teams, procurement and clinical engineering in healthcare organizations, and conformity assessment bodies use the standard to design, test and verify syringe products.

Q: Is it current or superseded?

A: The 2017 second edition is the current published edition and a corrected text was issued in August 2019; the standard was reviewed under ISO procedures and remains the active Part 1 document. Users should verify the status at the time of use for any later revisions.

Q: Is it part of a series?

A: Yes — ISO 7886 is a multipart series addressing different syringe types and features. Notable related parts include ISO 7886‑2 (pump syringes), ISO 7886‑3 (auto‑disable syringes) and ISO 7886‑4 (reuse‑prevention feature), along with other device and connector standards referenced in the text.

Q: What are the key keywords?

A: sterile hypodermic syringe, single use, syringe performance, plunger/stopper, dead space, leakage, medical device standard, ISO 7886‑1